DWO
11 FDA 510(k) clearances · Product code
46 daysmedian time to decision
89 days90th percentile
11clearances measured
FDA profile
- Official device name
- Needle, Biopsy, Cardiovascular
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.4800
- Medical specialty
- General, Plastic Surgery
- Adverse events (MAUDE)
- 2008: 7 · 2009: 9 · 2010: 7 · 2012: 9 · 2013: 11 · 2015: 8
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| PROMED BIOPSY NEEDLE (K933364) | Vlv Associates, Inc. | 1994-02-15 |
| ULTRA-CORE BIOPSY NEEDLES (K921418) | Medical Device Technologies, Inc. | 1992-06-19 |
| AUTOMATED BIOPSY DEVICE, MODIFICATION (K913815) | Hart Enterprises, Inc. | 1991-10-30 |
| MANAN BONE MARROW BIOPSY NEEDLE (K890925) | Manan Medical Products, Inc. | 1989-04-11 |
| MEDSURG GREENE NEEDLE (K885145) | Medsurg Industries, Inc. | 1989-03-14 |
| NEEDLE INSERT FOR SOFT TISSUE BIOPSY DEVICE (K885149) | Hart Enterprises, Inc. | 1989-01-26 |
| SOFT TISSUE BIOPSY DEVICE (K882013) | Ocean Medical Products, Ltd. | 1988-06-15 |
| ANGIOMED OSTY-CUT BONE BIOPSY NEEDLE (K874585) | Angiomed U.S., Inc. | 1987-12-02 |
| FINE NEEDLE ASPIRATION BIOPSY SYSTEM-PROSTATE (K872597) | Dianon Systems, Inc. | 1987-07-28 |
| ARGON CUT BIOPSY NEEDLES, VARIOUS SIZES (K853312) | Argon Medical Corp. | 1985-09-12 |
| RNG SERIES ULTRASOUND NEEDLE/CATH. GDS (K820269) | CIVCO Medical Instruments Co., Inc. | 1982-03-23 |
Track DWO automatically
Every clearance here is in the API, with alerts when new ones post.